When choosing a manufacturer, it is important to understand the facilities and procedures in place to ensure the safety of everyone. It is interesting to note that the FDA has had a recent impact on regulating the manufacture of liquid dietary supplements over the past two years.
The new fda drug statutes and regulations can be found in Title 21, Section 111. After a drug has been synthesized in the laboratory or purified from natural sources, the next step is usually animal testing. Commonly used animals include mice or rats. This is known as the pre-clinical testing phase.
If successful, applications for new drugs (IND) are submitted to the Food and Drug Administration (FDA). In the IND application, the protocol is for human experimentation. The FDA can dispute the protocol, but if not after 30 days, manufacturers can start testing.
Clinical studies are carried out in 3 stages. In phase 1, the drug is given to healthy volunteers who do not have the disease to be treated. It is used to check safety and to determine dosage. After Phase 2 is complete, the medicine will be given to people with this disease and also checked for safety and side effects. The numbers in this phase are small.
In phase 3, the drug will be given to a large number of people with the disease so that real statistical results can be obtained. The period for all 3 phases averages 5 years, but may be longer if the drug is complex or if there are not many patients with disease tested.